Journal of Food and Pharmaceutical Sciences
Vol 13, No 3 (2025): J.Food.Pharm.Sci

Proactive Risk Governance for Pharmaceutical Adulteration in Traditional Medicines: Evidence from Indonesia’s 2022–2025 Recalls

Kashuri, Mohamad (Unknown)



Article Info

Publish Date
29 Sep 2025

Abstract

Pharmaceutical adulteration in traditional medicines poses a persistent public health risk, particularly in countries with weak regulatory oversight. In Indonesia, recurring violations involving undeclared pharmaceutical substances (Bahan Kimia Obat, BKO) continue to surface despite existing post-market monitoring. This study aimed to examine the extent, trends, and systemic regulatory gaps associated with BKO in Indonesian traditional medicines between 2022 and early 2025. Using a qualitative document-based content analysis, the research reviewed official recall announcements and inspection records issued by the Indonesian Food and Drug Authority (BPOM). The findings revealed a sharp increase in BKO cases from 2022 to 2024, followed by a sudden drop in 2025, raising concerns about surveillance consistency. The adulterants detected became increasingly diverse, including anti-obesity drugs, corticosteroids, and psychiatric agents, reflecting a shift in consumer-targeted illicit formulation. Regulatory challenges identified include fragmented governance, lack of traceability systems, insufficient pre-market screening, and reliance on end-product testing. The study proposes reforms such as mandatory serialization, third-party testing, and realignment of licensing accountability to manufacturers. These insights suggest that current enforcement mechanisms are reactive and incomplete. Strengthening risk governance and integrating socio-behavioral dimensions into regulation are essential to prevent recurrence and protect public health.

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Journal Info

Abbrev

JFPS

Publisher

Subject

Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Immunology & microbiology Materials Science & Nanotechnology Medicine & Pharmacology Neuroscience

Description

Journal of Food and Pharmaceutical Sciences offers scientists, researchers, and other professionals to share knowledge of scientific advancements. The journal will publish original research articles, review articles, short communication, and letter to editor. The area of focus should cover all ...